Cosmetic & OTC/Drug Regulatory / Toxicology Support
About LEC Associates, LLC
LEC Associates has been providing regulatory and toxicology support to the cosmetic and US OTC/Drug industries for over 15 years. We support both start up and established companies. Our flexibility and extensive knowledge base allows us to quickly and effectively provide your business the regulatory support to sell your products in the global marketplace.
Services
We provide Responsible Person services thru our sister company LECEUR LTD. We have offices in both Europe + United Kingdom affording you a single Responsible Person contact for both regions. Please contact us for more details.
EU Consumer Product Safety Reports (CPSR) / Safety Assessments
We provide EU/UK compliant CPSR reports issued by our in house Board-Certified Toxicologist with over 40 years of industry experience.
US + Canadian Toxicological Risk Assessments (TRA)
Suitable for retailers' (Walmart, Target, Costco, QVC, etc) compliance requirements as well as safety substantiation MoCRA (Modernization of Cosmetic Regulation Act of 2022). In addition, we can provide California Prop 65 compliance checks.
MoCRA Registration of Cosmetic Products
Cosmetic product registration for MoCRA compliance.
US FDA Registration of OTC/Drug Products
We are able to act as a US Agent for foreign manufacturers. We will submit for the FDA Labeler Code, submit your FDA Establishment Registration and conclude with the FDA product listing.
EU + UK Cosmetic Product Notifications
As your Responsible Person, we submit product notifications on the EU Cosmetic Product Notification Portal (CPNP) and the UK Submit Cosmetic Product Notification Portal (SCPN).
Health Canada Cosmetic Notifications
We can submit product notifications to Health Canada in order to fulfill the requirement of selling cosmetics in Canada.
Cosmetic + OTC/Drug Label Reviews
In addition to packaging label reviews, we can also provide a review of product websites and marketing materials.
Formula Ingredient Review
With a robust ingredient database we are able to provide you with a compliance check for many regions. (US, EU/UK, Canada, ASEAN, LATAM, Australia, New Zealand) After review of the formula we are able to provide a list of ingredients for placement on packaging.
Please contact us for a full list of services
Contact us to find out how we can help.